ENMED Solutions works with appropriate manufacturers and suppliers and evaluates relevant documentation according to the product and destination market.

Quality and regulatory compliance are fundamental to international healthcare trade.

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Documentation Support

Healthcare products are subject to different regulatory requirements in different countries.

ENMED Solutions does not guarantee regulatory approval in a destination market. Final import approval, registration and market authorisation remain subject to the laws and authorities of the destination country.

Depending on product and destination requirements, documentation may include:

  • Certificate of Analysis
  • Certificate of Origin
  • Product specification
  • Manufacturing information
  • Batch documentation
  • Free Sale Certificate
  • Certificate of Pharmaceutical Product
  • MSDS/SDS
  • Packing List
  • Commercial Invoice
  • Product registration documentation
  • Other applicable regulatory documents

Where applicable, we consider:

  • Manufacturing credentials
  • Product documentation
  • Quality systems
  • Product specifications
  • Regulatory status
  • Export capability
  • Destination-market requirements